Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on operating limits and software improvements, not AI/ML capabilities.

Therapeutic

No
The device is explicitly stated to produce images that are useful in the determination of a diagnosis, indicating it is a diagnostic tool, not a therapeutic one.

Diagnostic

Yes
Explanation: The device produces images that, when interpreted by a trained physician, yield information useful in determining a diagnosis. This aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states "Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements." This indicates changes to the operating parameters of an existing hardware system (the Panorama MR Imaging System), not a standalone software device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is an "NMR device that produces images" and that these images are "interpreted by a trained physician" to "yield information that can be useful in the determination of a diagnosis." This describes an in vivo imaging system used for diagnostic purposes, not a device that performs tests on biological samples in vitro (outside the body).
Device Description: The description focuses on changes to operating limits and software improvements for an MR Imaging System, which is consistent with an in vivo imaging device.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the Panorama MR Imaging System, even with the described enhancements, functions as an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems as defined below:

The Panorama System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a training physician, these images yield information that can be useful in the determination of a diagnosis.

Product codes (comma separated list FDA assigned to the subject device)

90 LNH

Device Description

Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

head and whole body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K013858, K001796, K974844

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K002539, K981959, K013528, K983143

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

Kò2 4042

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1. General Information

| Classification: | Class II
Magnetic Resonance Imaging (MRI) System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Panorama Enhancements |
| Establishment Registration: | Manufacturing Location:
Philips Medical Systems
MR Technologies Finland Oy
P.O. Box 185
Vantaa, Finland
FIN-00511
Phone: 358925359300
FDA Facility Registration: #9680194
FDA Owner #1580240

Contact:
Attn: Duane C. Praschan
Philips Medical Systems (Cleveland)
595 Miner Road
Highland Heights, OH 44143
Phone: 440-483-5743 |
| Performance Standards: | No applicable performance standards have
been issued under section 514 of the Food,
Drug and Cosmetic Act |

2. Intended Uses

The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems as defined below:

The Panorama System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a training physician, these images yield information that can be useful in the determination of a diagnosis.

3. Device Description

Philips Medical Systems	Panorama Enhancements	11/22/02	Att I
MR Technologies Finland Oy		page 1 / 6

1

Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.

Safety and Effectiveness

The functionality included in the Panorama Enhancements are similar in technology characteristics and intended use to the Panorama 0.6T and 0.23T MR Imaging Systems and Philips' Intera family.

| Parameter | Panorama
0.6T MR
Imaging
System | Predicate Device

Philips Panorama
0.6T System
K013858
Philips Intera
family (0.5T, 1.0T,
1.5T) K001796 | Panorama 0.23
T MR Imaging
System | Predicate Device
Philips Panorama 0.6T System
K013858
Philips Panorama 0.23 T System
K974844
Philips Intera family (0.5T, 1.0T,
1.5T) K001796 |
|-------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gradient
Subsystem | | | | |
| Gradient Coils: | Same. | Water-cooled self-
shielded gradient
system. K013858 | Same. | Water-cooled self-shielded gradient
system. K974844 |
| Max. Gradient
Strength: | 23 mT/m. | 20 mT/m K013858 | 21 mT/m | 16 mT/m (x,y direction), 18 mT/m (z
direction) K974844 |
| Max. Slew
Rate: | 75 T/m/s. | 40 T/m/s K013858 | 50 T/m/s | 25 T/m/s (x,y direction), 40 T/m/s (z
direction) K974844 |
| RF Subsystem | | | | |
| RF amplifiers: | Same. | Max power 9 kW
K013858 | Same. | 5 kW solid state K013858 |
| RF transmitter
coils: | Same. | Upper and lower,
planar coils,
integrated in the
magnet, water
cooling. Tuning
adjusted to 0.6T field
strength. K013858 | Same. | Upper and lower, planar coils, integrated
in the magnet. Tuning adjusted to 0.23T
field strength. K013858 |
| Receive only
RF coils: | Same and
Synergy
Head and
Neck | Head, Head and
Neck, Neck,
Extremity, Body and
Spine, Multipurpose
(different sizes), TMJ,
Breast, Shoulder.
K013858 | Same and
Synergy Body. | Head, Brain, Head and Neck, Neck,
Extremity, Body and Spine (different
sizes), Flexible spine, Flexible Multi-
Purpose (different sizes), Small
Extremity (K974844)
Breast (K002539, MRI Devices Corp.)
Large Neck (K981959 Picker
International, Inc.)
TMJ (013528, USA Instruments, Inc.)
Shoulder (K983143,USA Instruments,
Inc.) |
| Magnet
Enclosure | | | | |
| Parameter | Panorama
0.6T MR
Imaging
System | Predicate Device
Philips Panorama
0.6T System
K013858
Philips Intera
family (0.5T, 1.0T,
1.5T) K001796 | Panorama 0.23
T MR Imaging
System | Predicate Device
Philips Panorama 0.6T System
K013858
Philips Panorama 0.23 T System
K974844
Philips Intera family (0.5T, 1.0T,
1.5T) K001796 |
| Magnet
Façade: | New design,
cover
backdoor of
ABS,
otherwise
material the
same. | Fiberglass enclosure.
K013858 | New design,
cover backdoor
of ABS,
otherwise
material the
same. | Fiberglass enclosure. K974844 |
| Operating
Software | | | | |
| Base Software: | Same. | Windows 2000 based
Graphical User
Interface and scan /
reconstruction
software with multi-
tasking capability.
K013858 | Same. | Windows 2000 based Graphical User
Interface and scan / reconstruction
software with multi-tasking capability.
K013858 |
| MRGP
software: | Same. | Interventional MRI
capabilities. K013858 | Same. | Interventional MRI capabilities.
K013858 |
| Imaging
sequences | | | | |
| Main features
include: | Same. | Field Echo, Spin
Echo, Dual Echo,
Dual Spin Echo,
Inversion Recovery,
Dual Inversion
Recovery, Fast Spin
Echo, EXPRESS,
CBASS, MRCP,
MRA, STIR,
FLAIR, TSHIRT, RF-
FAST, CE-FAST,
DWISE. K013858 | Same. | Field Echo, Spin Echo, Dual Echo, Dual
Spin Echo, Inversion Recovery, Dual
Inversion Recovery, Fast Spin Echo,
EXPRESS, CBASS, MRCP, MRA,
STIR, FLAIR, TSHIRT, RF-FAST, CE-
FAST, DWISE. K013858 |
| Acquisition and
reconstruction
techniques | | | | |
| Parameter | Panorama
0.6T MR
Imaging
System | Predicate Device
Philips Panorama
0.6T System
K013858
Philips Intera
family (0.5T, 1.0T,
1.5T) K001796 | Panorama 0.23
T MR Imaging
System | Predicate Device
Philips Panorama 0.6T System
K013858
Philips Panorama 0.23 T System
K974844
Philips Intera family (0.5T, 1.0T,
1.5T) K001796 |
| Main features
include: | Same. | Presaturation, MAST,
ODA, PCS, no phase
wrap-around, no slice
wrap around, dynamic
imaging, cardiac
gating, optimized
bandwidth, turbo
multislice.
MAO, MAST,
presaturation,
chemical fat
saturation, phase
conjugate symmetry,
read conjugate
symmetry, true res,
true slice, elliptic
encoding, RAM,
CODA, MTC,
dynamic examination
curve, contrast
dynamic imaging,
reconstruction filters,
respiratory gating,
multiplanar
reconstruction,
maximum intensity
projection, phase
correction, fat/water
suppression, ADC
map. K013858
SENSE capability.
K001796
SyncraScan | Same. | Presaturation, MAST, ODA, PCS, no
phase wrap-around, no slice wrap
around, dynamic imaging, cardiac
gating, optimized bandwidth, turbo
multislice.
MAO, MAST, presaturation, chemical
fat saturation, phase conjugate
symmetry, read conjugate symmetry,
true res, true slice, elliptic encoding,
RAM, CODA, MTC, dynamic
examination curve, contrast dynamic
imaging, reconstruction filters,
respiratory gating, multiplanar
reconstruction, maximum intensity
projection, phase correction, fat/water
suppression, ADC map. K013858
SENSE capability. K001796
SyncraScan |
| User Interface | Layout
change, see
Figure 2b. | Layout, see Figure 2a. | Layout change,
see Figure 2b. | Layout, see Figure 2a. |
| Time Varying | | | | |
| Parameter | Panorama
0.6T MR
Imaging
System | Predicate Device
Philips Panorama
0.6T System
K013858
Philips Intera
family (0.5T, 1.0T,
1.5T) K001796 | Panorama 0.23
T MR Imaging
System | Predicate Device
Philips Panorama 0.6T System
K013858
Philips Panorama 0.23 T System
K974844
Philips Intera family (0.5T, 1.0T,
1.5T) K001796 |
| Normal
Operating
Mode: | ≤ 35.4 T/s
(IEC60601-
2-33,
second
edition,
directly
determined) | According to IEC
60601-2-33 FDIS
script 2001-11-02,
default. K013858 | ≤ 35.4 T/s
(IEC60601-2-
33, second
edition, directly
determined) | ≤ 40 T/s K974844 |
| First Level
Controlled
Operating
Mode: | ≤ 44.3 T/s
(IEC60601-
2-33,
second
edition,
directly
determined) | According to IEC
60601-2-33 FDIS
script 2001-11-02,
default. K013858 | ≤ 44.3 T/s
(IEC60601-2-
33, second
edition, directly
determined) | ≤ 60 T/s K974844 |
| Radiofrequency
Absorption | | | | |
| Normal
Operating
Mode: | Same. | Limited to a
maximum level of 1.2
W/kg. K013858 | Same. | Limited to a maximum level of 1.2
W/kg. K974844 |
| First Level
Controlled
Operating
Mode: | Same. | Limited to a
maximum value of
3.2 W/kg.
K013858 | Same. | Limited to a maximum value of 3.2
W/kg.
K974844 |
| Acoustic Noise | | | | |
| Typical: | Same. | 87 dBA (average)
102 dBA (peak)
K013858 | Same. | A-weighted average value